Effects of Repetitive Transcranial Magnetic Stimulation on Two Cerebellar Targets
StimCervelet
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to understand how different areas of the cerebellum (a part of the brain) control different functions and how they can be influenced by non-invasive brain stimulation. While researchers know that repetitive Transcranial Magnetic Stimulation (rTMS) can have positive effects on conditions like stroke and schizophrenia, they do not yet fully understand which specific stimulation settings work best or which exact parts of the cerebellum should be targeted for different symptoms. This study compares the effects of stimulation on two specific regions:
- Lobule VIII: Linked to movement and motor learning.
- CRUS I/II: Linked to attention, thinking (cognition), and predicting the timing of events.By comparing these areas, researchers hope to gain the information needed to develop better treatments for neurological and psychiatric disorders. This is a randomized, double-blind study involving 40 healthy volunteers. Participants will be split into two groups:
- Group 1: Receives "exciting" (activity-increasing) stimulation.
- Group 2: Receives "inhibiting" (activity-decreasing) stimulation. Each participant will attend three different test sessions in a random order:
- rTMS targeting Lobule VIII
- rTMS targeting CRUS I/II
- Placebo (Sham) stimulation that looks and feels like the real thing but does not affect the brain. During each session, researchers will use brain imaging (fMRI) and computerized tasks to measure changes in brain connectivity and performance in motor and cognitive activities. There is no direct medical benefit to the participants. However, the results will help scientists create better therapies for patients with brain-related health issues The risks are considered minimal. Common side effects of rTMS include temporary mild headaches or a clicking sound during stimulation. MRI scans can sometimes cause mild discomfort or a feeling of closed-in spaces (claustrophobia). Researchers have put safety measures in place, such as hearing protection and constant medical supervision during scans, to minimize these risks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Sep 2026
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2030
Study Completion
Last participant's last visit for all outcomes
January 2, 2030
May 1, 2026
April 1, 2026
3.3 years
April 17, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Resting-State Functional Connectivity (RSFC) Measured by functional Magnetic Resonance Imaging (fMRI, expressed as Fisher's z-transformed correlation coefficients) within Cerebellar-Thalamo-Frontal and Cerebellar-Parieto-Motor Networks.
Functional imaging data will be pre-processed according to standard procedures: slice-timing correction, intra-run spatial realignement, inter-run realignement, distortion and motion artifact correction, band-pass filtering to remove physiological noise, and normalization into the MNI common space, followed by smoothing using FSL and SPM12 software.Subsequently, the signal within the networks of interest will be extracted using the "Conn" toolbox and compared using a General Linear Model (GLM). Connectivity maps will be generated from specific "seed" regions of interest (Crus I/II and lobule VIII), where each voxel value corresponds to the correlation with the seed region.
Baseline (Pre-stimulation) and 1-hour post-stimulation
Study Arms (12)
1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory
EXPERIMENTALParticipants receive active rTMS to Lobule VIII in the first session, followed by active rTMS to Crus I/II in the second, and Sham stimulation in the third.
2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory
EXPERIMENTALParticipants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II.
3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory
EXPERIMENTALParticipants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation.
4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory
EXPERIMENTALParticipants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII.
5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory
EXPERIMENTALParticipants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II.
6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory
EXPERIMENTALParticipants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII
1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory
EXPERIMENTAL2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory
EXPERIMENTAL3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory
EXPERIMENTAL4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory
EXPERIMENTAL5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory
EXPERIMENTAL6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory
EXPERIMENTALInterventions
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
Participants receive rTMS targeting the Crus I/II of the cerebellum. Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
The coil looks and sounds identical to the active coil and is placed in the same positions (counterbalanced between Lobule VIII and Crus I/II sites). It provides the physical sensation and auditory "click" of TMS without delivering a significant magnetic field to the brain tissue, maintaining the study's double-blind integrity.
Participants perform three computerized tasks to evaluate the functional impact of the rTMS: * Visuomotor Task: A joystick-based task assessing motor coordination and learning (linked to Lobule VIII). * Temporal Prediction Task: A visual task requiring the participant to predict the timing of an event (linked to Crus I/II). * Mental Imagery \& Finger Tapping: A task assessing the cognitive representation of movement.
Eligibility Criteria
You may qualify if:
- Subject, male or female, aged between 18 and 60 years inclusive
- Subject affiliated with or a beneficiary of a social security health insurance scheme
- Subject has dated and signed the informed consent form prior to the start of any trial-related procedures
- For women of childbearing potential, a negative urinary pregnancy test and the use of effective contraception throughout the duration of the study
You may not qualify if:
- Subject with substance use disorders (as defined by the DSM-5)
- Subject suffering from a neurological pathology or sequelae
- Subject with Attention-Deficit/Hyperactivity Disorder (ADHD)
- Subject with Borderline Personality Disorder
- Subject presenting with disabling sensory impairments, specifically a visual acuity (corrected, if applicable) \< 0.8 (due to the use of visual materials; Freiburg Vision Test, Bach 1996; verified during an examination at the screening visit)
- Subject deprived of liberty or under legal protection
- Subject under guardianship or trusteeship
- Pregnant or breastfeeding woman (verified by a urinary test at the screening visit)
- Subject presenting a contraindication for fMRI or rTMS: presence of non-removable ferromagnetic bodies, prostheses, pacemakers, implanted medication pumps, vascular clips or stents, heart valves or ventricular shunts, certain intracerebral clips, cochlear implants, history of seizures (epilepsy), or skin breach/pathology at the point of contact with the electrodes
- Subject with a history of major neurological or psychiatric disease with current psychotropic medication (i.e., antipsychotics, benzodiazepines and related compounds, or hypnotics)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Strasbourg, Francelead
- ICube Laboratorycollaborator
Study Sites (1)
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Only the personnel specifically operating the rTMS platform will have knowledge of the type of stimulation (active target VIII, active target Crus I/II, or Sham) being administered to each participant. This ensures that both the volunteer and the research team evaluating the behavioral and imaging data remain unaware of the intervention assignment until the end of the analysis phase.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2026
First Posted
May 1, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
January 2, 2030
Study Completion (Estimated)
January 2, 2030
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share